Biogen Idec Submits FDA Application for Long-Acting FIX Therapy

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Biogen Idec Submits FDA Application for Long-Acting FIX Therapy

February 1, 2013

In January Biogen Idec submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for marketing approval of the company’s long-lasting recombinant factor IX Fc fusion protein (rFIXFc) for the treatment of individuals with hemophilia B. The BLA was based on positive results from B-LONG, a global Phase III clinical study of rFIXFc.

“The submission to FDA of rFIXFc is an important milestone towards the introduction of a long-lasting factor IX therapy which is the first major treatment advance for the hemophilia B community in 15 years,” said Glenn Pierce, MD, PhD, senior vice president of Global Medical Affairs and chief medical officer of Biogen Idec’s hemophilia therapeutic area. “Our Fc fusion technology uses a natural pathway in the body to keep factor in circulation longer. The clinical efficacy and safety data for rFIXFc were robust and showed that dosing every one to two weeks provided significant protection from bleeding. Based on these data, we believe rFIXFc has the potential to have a major impact on the global adoption of prophylactic treatment in hemophilia B, helping patients prevent bleeding episodes and potentially reduce their long-term consequences.”